MDCG 2021-21 Rev. 1 : Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices – August 2021

This document details the performance evaluation conditions for IVD’s intended for the detection or quantification of:

• SARS-CoV-2 nucleic acid,
• SARS-CoV-2 antigens,
• antibodies to SARS-CoV-2.

This MDCG comes in the absence of common specifications in this area but may serve as a basis for future common specifications that will be developed in the near future under Article 9 of Regulation (EU) 2017/746.